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Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma

NCT03757221 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-05-13

No results posted yet for this study

Summary

Multiple myeloma is an incurable hematological malignancy that affects older patients. Currently, despite recent progress, the disease relapses more or less quickly after initial treatment and requires the resumption of treatment with new drugs associated with cortisone, whose side effects are important. The investigators propose to conduct a phase 2 testing the combination ixazomib - daratumumab without dexamethasone.

Conditions

Interventions

COMBINATION_PRODUCT

Ixazomib and Daratumumab

Daratumumab will be administrated every week for the first 2 cycles. For cycle 3 to 6, it will be administrated every two weeks at day 1 and day 15. From cycle 7 until progression Daratumumab will be administrated every 4 weeks. Ixazomib will be administrated every week three weeks on one week off at D1, D8 and D15 on a 28-d cycle basis. Dexamethasone will not be given except one series of 4 days of dexamethasone, 20 mg/day or a maximum of 80 mg, for emergencies and complications at initiation of treatment.

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2022-09-15
Completion
2024-04-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757221 on ClinicalTrials.gov